Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Severe Renal Impairment and Normal Renal Impairment
NCT06671444 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2024-11-04
Summary
Objective:
1. To evaluate the pharmacokinetics of YZJ-1139 tablets in patients with severe renal impairment and in subjects with normal renal impairment.
2. To evaluate the safety of YZJ-1139 tablets in patients with severe renal impairment and in subjects with normal renal impairment.
Conditions
- Insomnia
- Renal Impairment
Interventions
- DRUG
-
YZJ-1139
Single oral dose, 20 mg tablet
Sponsors & Collaborators
-
Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-06-03
- Primary Completion
- 2024-11-10
- Completion
- 2024-12-25
Countries
- China
Study Locations
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